Company ยท US
Theragenics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2011. Name variants (Inc, Corp, punctuation) are merged.
5510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 3, 2011 | K103319 | I-SEED Theragenics Corp. | KXK |
| Sep 26, 2007 | K072296 | POIINT OF CARE STRANDING SYSTEM, MODE 1004-00 Theragenics Corp. | KXK |
| Jan 26, 2005 | K043596 | THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 Theragenics Corp. | KXK |
| Apr 26, 2001 | K010283 | THERASEED(R) PALLADIUM-103 IMPLANT; MODEL 200 Theragenics Corp. | KXK |
| Dec 22, 1987 | K874787 | MODIFIED PALLADIUM SEED MODEL 100 Theragenics Corp. | IWI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 9, 2018 | Theragenics Corporation Theragenics Applicator Needle (18g x 20cm)
The device is comprised four basic elements; a wire stylus with plastic handle, a plastic needle hub, a protective needle sleeve and the hollow steel needle Terminated |
IWJ | None listed |
| Mar 31, 2009 | Theragenics Corporation Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. Theragenics Corporation, 5203 Bristol Industrial Way, Buford GA 30518.
The Terminated |
NQO | K072296 |
| Jul 7, 2005 | Theragenics Corporation PG910 Spacers, Part number SP101, loaded into Bard Express Seeding Cartridges containing TheraSeed Pd-103 devices. The product is shipped non-sterile in a foil pouch, packed 50 loose spacers per pouch Terminated |
KXK | None listed |